The First Oral Treatment For Postpartum Depression Has Been Approved by the FDA—Why Did It Take So Long?

Earlier this month, the United States Food and Drug Administration (FDA) announced its approval of zuranolone (brand name: Zurzuvae) as the first oral medication for the treatment of postpartum depression (PPD). For many, this was a groundbreaking moment in the history of women’s health. But if you ask me, a clinical psychologist and mother of three who has fought her own postpartum mental health battles, it’s taken far too long to get here.

Postpartum depression isn’t new. Hippocrates was the first to note mental health concerns in postpartum women in the 4th century BC, yet PPD became a diagnosable clinical disorder only 30 years ago (in 1994) when it was introduced in the Diagnostic and Statistical Manual of Mental Disorders–Fourth Edition. 

More recently, PPD has gained national attention as celebrities such as Adele and Brooke Shields have opened up about their experiences and news outlets have put the spotlight on the tragic stories of women experiencing postpartum psychosis.

Postpartum depression also isn’t uncommon. The disorder affects approximately 1 in 7 women. Symptoms typically appear within the first few weeks of a woman giving birth; however, experts note they can also begin during pregnancy and persist for a year after childbirth. 

These symptoms include those typical of major depressive disorder (MDD)—low mood, loss of interest in activities, lack of energy, increased fatigue, feelings of guilt and worthlessness, difficulty concentrating, and more—and are difficult for anyone to function with, let alone the mother of a newborn.

PPD includes symptoms that make it especially difficult for a woman to care for her child: lack of interest in and connection with the baby, feelings of being a bad mother, and fears of harming baby or self are just some of them. Left untreated, PPD can persist for months or years.

I experienced PPD after having my oldest son. At first, I figured the frequent irritability I felt and tears I shed were due to the fatigue and exhaustion that went hand in hand with my newfound disrupted sleep schedule, around-the-clock nursing and pumping, and general stress of learning to keep a human alive.

But as the months went on and my son became a solid sleeper, breastfed less, and was clearly thriving, I realized that I wasn’t just tired. I was apathetic and numb. I didn’t feel connected to my own child. I didn’t really care to be a mom. And because I felt these things, I also felt ashamed and alone.

Related Read: The Moms Are Not OK: Why Mental Health is Keeping Mothers Up at Night

Prior to the FDA’s announcement, treatment for PPD did exist. And because of my experience as a clinical psychologist, I had an upper hand. I had learned about PPD, I had worked with individuals with PPD, and I had a community of colleagues and friends to turn to for help. 

Many women I’ve met who have struggled with PPD haven’t had the same experience. They may suffer in silence because of the shame of some of these feelings, or find it difficult to access or find time for proper care.

Here’s a look at the current treatment options available. 

Treatment Options For Postpartum Depression

• Psychotherapy

• Antidepressant medications

• Intravenous brexanolone

• Zuranolone (new)

Psychotherapy

Psychotherapy has been a first-line treatment option for women with mild to moderate symptoms or those who were hesitant to take medications while nursing; however, the logistics of finding a therapist and making time for a weekly 45-minute to 1-hour appointment prevent many women from engaging in it.

Antidepressant Medications 

Selective serotonin reuptake inhibitors (SSRIs) have been recommended for women with moderate to severe depression and are largely considered safe to use while breastfeeding; however, many nursing mothers remain concerned about antidepressants’ impact on milk production and passage into breast milk. It can also take several weeks for antidepressants to have a noticeable effect, which is too long to wait for mothers who want and need to feel like themselves and care for their very young children. 

Intravenous Brexanolone

Intravenous brexanolone requires patients to enroll in the FDA’s Risk Evaluation and Mitigation Strategy Program and travel to certified healthcare facilities for a continuous intravenous infusion over a period of 60 hours.

Zuranolone

In contrast, the new zuranolone option is a much more accessible option for mothers, as it is an oral medication that can be taken in the privacy of one’s home. And a 14-day course of treatment has been shown to have a rapid, clinically meaningful, and sustained effect. 

I, personally, benefitted from individual psychotherapy. But the reality is, I had a relatively mild case of PPD, I was lucky enough to find a therapist who was a great fit for me, and I was privileged enough to have the resources and time to set aside an hour each week for treatment. Unfortunately, that’s not the case for everyone, and this new option will be a game-changer for so many mothers. 

So, given how long PPD has been around, how prevalent it is, how much suffering it can cause, and how hard it has been for affected women to access treatment, why has it taken so long for zuranolone to arrive?

The answer isn’t so clear. Some argue that women are underrepresented in clinical trials. While it is true that women have historically been underrepresented in research, their inclusion has increased over time. (The percentage of women included in FDA trials of emerging drugs over the past 6 years has ranged from 40% to 72%.) And in 2016, the 21st Century Cures Act was signed into law and helped establish a task force on research specific to pregnant and lactating women (PRGLAC) to identify gaps in the development of safe and effective therapies for these groups.

But even as the research world has advanced to consider the needs of women and mothers, the U.S. healthcare system has not. In fact, it has largely treated mothers as an afterthought. 

Journalist Allison Yarrow highlights this in her TED talk, noting that after being discharged from the hospital a mere 48 to 72 hours after the physically intensive, body-altering, and life-changing ordeal that is childbirth, women do not come into contact with a healthcare professional until their 6-week postpartum check-up. 

Is it that surprising, then, that the U.S. maternal death rate is more than triple that of other high-income countries, or that mental health conditions are the leading cause of pregnancy-related deaths in America?

As I’ve implored to readers before in the article The Moms Are Not OK, there is so much more we can and should do to support mothers. On an individual level, this can be:

• Offering emotional and practical support to mothers we know, whether that be providing a listening ear or helping with childcare and/or household tasks so that mothers have a moment for themselves.

• Doing our part to destigmatize PPD by voicing our concern and compassion when we notice a mother we know struggling and encouraging her to seek professional support.

• Spreading the word about national resources like the National Maternal Mental Health Hotline, an around-the-clock hotline for new and pregnant moms.

• Advocating for policies at our workplaces, in our communities, and at the state and national level to provide mothers with adequate support.

The arrival of zuranolone is indeed groundbreaking and we should be shouting our joy from the rooftops. And yet, it reveals a sad truth about how we’ve ignored the needs of mothers for far too long. Let’s work on changing the story together.